Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of low dose raltegravir

Conditions: HIV Infections

Summary: the purpose of this study is to study and compare the pharmacokinetics profile of low dose raltegravir (ral) (400mg od and 800mg od) and standard dose of 400mg bid in thai hiv-infected patients.

twenty four hiv-infected volunteers on stable doses of ral 400 mg bid for at least 3 months and with undetectable viral load will be enrolled. on day 1, all 24 subjects will attend the first intensive pk collection for ral 400 mg bid and the blood samples will be drawn at t = 0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 hour post medication. all 24 subjects will be randomised (1:1) to either group a (ral 400 mg od) or group b (ral 800 mg od) for 14 days. on day 15, a second 24 hour intensive pk will be carried out and the blood samples will be drawn. after 2nd intensive pk, the subjects will switch to the other dosing regimen. subjects in group a will receive ral 800 mg od and group b will receive ral 400 mg od for another 14 days. on day 29, the third 24 hour intensive pk will be carried out. after the 3rd intensive pk, all 24 subjects will be switched back to the initial regimen of ral 400 mg bid.

Eligibility criteria:
inclusion criteria: * signed informed consent * evidence of hiv infection * age\> 18 years * on ral 400 mg bid containing haart regimen with a vl \< 50 copies for at least 3 months before enrollment * willing to adhere to the protocol requirements exclusion criteria: * evidence of ral resistance * history of ral allergy * use of concomitant medication that may interfere with the pharmacokinetics of ral * current pregnancy or lactating or planning to get pregnant * active drug abuse or alcoholic * relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.

Keywords: pharmacokinetics low dose raltegravir hiv to study the pharmacokinetics profile of low dose raltegravir (ral) (400mg od and 800mg od) and standard dose of 400mg bid in thai hiv-infected patients.
safety and pharmacokinetics/pharmacodynamics of shr3824 in type 2 diabetes patients with renal insufficient

Conditions: Renal Insufficiency,Type 2 Diabetes

Summary: the purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of shr3824 in type 2 diabetes patients with renal insufficient.

this trial was a parallel, open-label, single dose study. the subject was divided into one of three groups according to the degree of renal insufficiency,including normal, mild and moderate. all subjects were given shr3824 20mg, the blood and urine samples were collected before and after dosing.

Eligibility criteria:
inclusion criteria: * with a body mass index(bmi) between 19 and 33 kg/m2; * the estimated glomerular filtration rate (egfr)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;moderate renal insufficiency: 30 to 59 ml/min/1.73m2. * had signed the informed consent himself or herself voluntarily. exclusion criteria: * urinary tract infections, or vulvovaginal mycotic infections * suspected or diagnosed as kidney cancer or other malignancies in patients * autoimmune kidney disease, history of renal transplantation, dialysis patients being treated * history of or current clinically significant medical illness as determined by the investigator * history of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * known allergy to shr3824,sglt2 inhibitor analogs, or any other structural analogs * alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;tobacco is defined as five or more per day. * pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. * researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Keywords: efficacy pk/pd study renal insufficiency type 2 diabetes
total knee arthroplasty infiltration study for postoperative analgesia

Conditions: Postoperative Pain

Summary: this is a phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (tka) to evaluate the analgesic efficacy, safety, and pharmacokinetics (pk) of htx-011 administered via infiltration to the surgical site.


Eligibility criteria:
inclusion criteria: * is scheduled to undergo primary unilateral tka under general anesthesia. * has not previously undergone tka in either knee. * has an american society of anesthesiologists physical status of i, ii, or iii. * is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance. * female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. exclusion criteria: * has a planned concurrent surgical procedure (eg, bilateral tka). * has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain. * has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications. * has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * has taken nsaids within 10 days prior to the scheduled surgery. * has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting). * has been administered bupivacaine within 5 days prior to the scheduled surgery. * has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. * has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * has a medical condition such that, in the opinion of the investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * has a known history of hepatitis b, human immunodeficiency virus (hiv), or active hepatitis c. * has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments. * has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. has any chronic condition or disease that would compromise neurological or vascular assessments. * had a malignancy in the last year, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. * received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. * has undergone 3 or more surgeries within 12 months. * has a body mass index (bmi) \>38 kg/m2.

Keywords: knee knee replacement arthroplasty joint replacement knee pain
exploratory clinical trials of acm-1 in the treatment of ophthalmological neovascular diseases

Conditions: Neovascularization, Pathologic

Summary: the purpose of this study is to investigate the role of intravitreal injection of anti-vascular endothelial growth factor (vegf) therapy in prevention and control of ophthalmological neovascular diseases, in order to find a new strategy of treatment for ophthalmological neovascular diseases

ophthalmological neovascular disease is one of the major causes of blindness in ocular diseases. up to now, the major treatment strategies include: anti-vegf therapy, laser therapy and surgery. clinical treatment have revealed that intravitreal injection of anti-vegf can effectively restrain neovascularization. nevertheless, it requires repeated injections, may result in various complications, and may be ineffective in some patients. therefore, it is necessary to find out other targets which causes retinal neovascularization, in order to find more effective treatments for patients who fail to respond to anti-vegf therapy. previous researches have shown that herb monomer (acm-1) was effective in inhibiting leakage of retinal vessels and neovascularization. so in this study, patients with ophthalmological neovascular diseases will be treated with intravitreal injection of acm-1, in order to investigate the role of intravitreal injection of acm-1 therapy in prevention and control of ophthalmological neovascular diseases.

Eligibility criteria:
inclusion criteria: 1. age range from 18 to 75 years old 2. without light perception (nlp) 3. a large number of iris or retinal neovascularizations, neovascular glaucoma who needs cyclophotocoagulation or enucleation of eyeball 4. the best corrected visual acuity of the contralateral eye is better than 0.05 5. follow-up for more than six months 6. volunteer for this project and sign the informed consent exclusion criteria: 1. the best corrected visual acuity of the contralateral eye is lower than 0.05 2. severe systemic disease or other surgical contraindication 3. history of antiangiogenic therapy within one month 4. ocular neovascularization was caused by other reasons,such as endophthalmitis 5. history of joining in drug clinical trial within one month(except for vitamins and minerals) 6. pre-menopausal women who do not use birth control 7. people are currently being treated for systemic infections 8. allergic to fluorescein 9. hypertension(sbp is higher than 140mmhg) 10. hepatic renal dysfunction 11. history of drug abuse or alcoholism 12. other situation which will impede the clinical trial, as such depressive disorder 13. the compliance is too poor to finish the clinical trial

Keywords: acm-1 intravitreal injection neovascularization
therapeutic plasmapheresis in critically ill adult patients with covid-19 confirmed diagnosis

Conditions: COVID-19

Summary: introduction: the sars-cov-2 outbreak has left more than two million infected worldwide in the first four months of covid-19 epidemic. to date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease. aim: to establish clinical response of critically ill patients with covid-19 who received convalescent plasma from subjects recovered from sars-cov-2 during their stay in intensive care unit at fundación cardiovascular de colombia (hospital internacional de colombia). methodology: quasi-experimental study (no randomization will be performed). adult patients who meet selection criteria will receive 500 ml of abo compatible convalescent plasma, obtained by apheresis from patients recovered from sars-cov-2 infection. the main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of abo compatible plasma units. a survival analysis will be performed using kaplan-meier method and association strength will be reported using hr and 95% ci crude and adjusted for confounding variables. expected results: it is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.


Eligibility criteria:
inclusion criteria: * age range: over 18 years old * patients with confirmed infection by covid-19 (positive real-time pcr) in icu with: * respiratory failure receiving ventilatory support and high parameters * severe pneumonia with rapid progression * ability to sign informed consent exclusion criteria: * pregnant women * contraindication of plasma administration due to history of anaphylaxis during transfusions

Keywords: covid-19 convalescent plasma intensive care unit critical illness
pba use for treatment of atf6-/- patients

Conditions: ACHROMATOPSIA 7; Achromatopsia

Summary: some patients with achromatopsia, an inherited disorder characterized by partial or complete loss of color vision, carry mutations in atf6. atf6 is a gene that is responsible for coding a protein that acts in response to endoplasmic reticulum (er) stress. when the atf6 protein is mutated, retinal function decreases, contributing to color blindness. the study aims to investigate whether an already fda-approved drug, glycerol phenylbutyrate (pba), can improve retinal function inpatients with achromatopsia caused by atf6 mutations. patients will be instructed to take three doses of pba per day at equally divided time intervals and rounded up to the nearest 0.5 ml. the total dose of pba will be 4.5 to 11.2 ml/m2/day (5 to 12.4 g/m2/day) and will not exceed 17.5 ml/day (19 g/day). their condition will be monitored over the course of a minimum of 3 clinic visits that will consist of a number of retinal function tests, fundus examinations, and imaging procedures. findings from the study could elucidate the potential for pba to serve as a treatment for patients with atf6-mediated a chromatopsia.

atf6 has been described as an endoplasmic reticulum (er) stress-regulated transmembrane protein that activates the transcription of molecular chaperones in response to er stress. patients harboring mutations in atf6 present with decreased retinal function and are diagnosed with achromatopsia. the investigator's research group has previously demonstrated that administration of glycerol phenylbutyrate (pba), a fatty acid compound that facilitates protein folding, can lead to enhanced retinal function in mice that are homozygous for the atf6 mutation. this study will investigate the effects of pba administration in two patients who carry atf6-/- mutations and a diagnosis of achromatopsia. enrolled subjects will undergo a minimum of 3 clinic visits that consist of a complete ophthalmic examination (best-corrected visual acuity, intraocular pressure, anterior segment examination, slit lamp and binocular fundus examination), a visual functioning questionnaire, color vision tests, contrast sensitivity tests, retinal imaging (optical coherence tomography, short wavelength autofluorescence and near-infrared autofluorescence), a macular sensitivity test (nidek microperimetry) and full-field electroretinogram (fferg). a blood draw will be performed at each visit to test for any indications of adverse effects from drug use. subjects will be instructed to take 3 doses of pba per day, totaling to a dose of 4.5 to 11.2 ml/m2/day (5 to 12.4 g/m2/day).

Eligibility criteria:
inclusion criteria: * patients harboring mutations in atf6 present with decreased retinal function exclusion criteria: * patients who are minors * patients who are pregnant

Keywords: achromatopsia pba atf6 color blindness
using ecological momentary assessment to develop an adaptive psychological intervention for young adults with chronic pain

Conditions: Chronic Pain

Summary: the goal of this observational study is to determine real-time contextual vulnerabilities associated with pain in young adults to inform ideal treatment targets for a just-in-time adaptive intervention (jitai). the main question it aims to answer is: -what contextual factors and vulnerabilities will predict momentary, next-day, and weekly pain severity? 50 young adults, ages 18-25 with a diagnosis of childhood-onset primary chronic pain, will complete 1) baseline questionnaires on redcap to collect data on sociodemographics, medical history and treatment, psychological health (i.e., current mood symptoms and previous psychiatric conditions/treatment), and pain (e.g., duration, location) and 2) a 28-day ema via mobile app to collect survey data on dynamic factors.


Eligibility criteria:
inclusion criteria: * ages 18-25 * diagnosis of childhood-onset chronic pain who were seen for an initial evaluation at seattle children's hospital outpatient specialty clinics. exclusion criteria: * not fluent in english * does not have regular access to the internet and access to a smartphone device (to complete ema questions) * presence of chronic disease or serious medical illness (e.g., arthritis, cancer, diabetes) * serious cognitive impairment or developmental disorder (e.g., autism, intellectual disability)

Keywords: ema study childhood onset chronic pain young adult cannabis use real-time predictors health outcomes
the effect of wound irrigation with irrisept on abscess healing (irrisept uf study)

Conditions: Abscess

Summary: the purpose of this study was to evaluate the safety and effectiveness of irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.

after being informed about the trial and potential risks, subjects completed an informed consent form prior to participation. after eligibility criteria was verified, an initial wound assessment examination was performed. subjects were then randomized to the irrisept or standard of care treatment group. at intervals of 48 hours (up to 96 hours) later, abscesses were assessed until healing occurred. if the subject required antibiotics, this was recorded, as well as results from the wound and methicillin-resistant staphylococcus aureus (mrsa) cultures.

Eligibility criteria:
inclusion criteria: 1. immunocompetent individuals, 12 years of age or older with an uncomplicated abscess 1. uncomplicated abscess is defined as ≤8 cm of induration (defined as firmness to touch) at the greatest diameter. 2. ≤4 cm of surrounding erythema (surrounding redness). 2. defined area of central fluctuance may or may not be present. 3. patient must be able to answer questions. 4. patient must be medically stable as defined by the emergency department physician. 5. patient must participate voluntarily in the study. exclusion criteria: 1. currently receiving antibiotics or received antibiotics within the last 72 hours. 2. evidence of systemic infection (fever, aches, chills, nausea). 3. requires admission to the hospital for infection or for any other reason(s). 4. abscess caused by a human or animal bite. 5. prior history of hypersensitivity or allergy to chlorhexidine gluconate (chg). 6. immunodeficiency (examples: hiv positive, crohn's disease, systemic lupus erythematosus, addison's disease, psoriasis, splenectomy, leukemia, cancer (on chemotherapy)). 7. currently on any immune-modifying medication (examples - prednisone, antivirals). 8. history of chronic skin infection (3 or more in the past year). 9. chronic medical problem (for example, end-stage heart, liver, kidney or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant). 10. mental illness, including but not limited to, substance abuse, dementia, schizophrenia or mentally handicapped or challenged. 11. incarcerated. 12. patient is pregnant or thinks she may be pregnant.

Keywords: wound irrigation
prevention of lateral epicondylalgia in handgun olympic shooting athletes

Conditions: Epicondylitis, Lateral

Summary: lateral epicondylalgia is one of the most common pathologies suffered by olympic gun shooting athletes. in spain, there is hardly any research carried out in this sport, so there are no injury prevention protocols available. preventing these injuries would be fundamental to improve the performance of athletes and to be able to continue adding successes to national honors. it has also been evidenced that if exercise is combined with stretching, the benefits of physical therapy are increased. high-quality studies have stated that it is not necessary for this exercise protocol combined with stretching to be very prolonged over time, as they affirm that significant improvements can be achieved with only four weeks of exercise. this study aimed to test the hypothesis that olympic handgun shooting athletes who perform a four-week multimodal exercise program combined with stretching have a lower risk of suffering from lateral epicondylalgia than athletes who do not perform this program, determining its effectiveness for pain prevention.


Eligibility criteria:
inclusion criteria: * adults aged \>35 years * present a risk of suffering from lateral epicondylalgia * be in possession of a federation olympic shooting license * practice olympic shooting with handgun and carry out at least one olympic shooting training session a week or have participated in the last three months in an official competition exclusion criteria: * subjects who had serious uncontrolled illnesses * who had undergone surgery as a treatment for lateral epicondylalgia * who had received treatment for lateral epicondylalgia in the last month or injections of corticosteroids or steroids for this pathology in the last 6 months * who had suffered a serious upper limb injury in the last year or present a risk of suffering epicondylalgia due to a cause other than olympic shooting

Keywords: prevention epicaondylalgia exercise stretching
excitability protocol: voltage-gated ion channels

Conditions: Pain

Summary: the purpose of subproject 1 is to evaluate the accuracy of a nerve excitability protocol in healthy subjects before testing the protocol in diabetic neuropathy patients. the nerve excitability protocol has been derived by computational modeling to identify abnormalities of three subtypes of ion voltage-gated channels. these three ion channels are all altered in animal models of diabetic neuropathy and, therefore, are likely candidates for generating the altered excitability in diabetic neuropathy patients. the hypothesis for subproject 1 is that due to the unique dynamics of each subtype of voltage-gated ion channels, it is possible to identify abnormal voltage-gated ion channel alterations by altering the shape of the electrical stimulation.


Eligibility criteria:
inclusion criteria: healthy men and women in the age 18-80 years who speak and understand english. exclusion criteria: * pregnancy or breast feeding * drug addiction defined as the use of cannabis, opioids or other drugs * previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression) * skin diseases * past history of conditions possibly leading to neuropathy * inability to cooperate * current use of medications that may affect the study, e.g., analgesics * previous traumatic experience of an electrical accident * consumption of alcohol or painkillers within the last 24 hours * participation in other pain studies throughout the study period * patients with cardiac diseases (e.g., pacemaker).